Mobility Protocol Adapted for Advanced Visually Impaired Subjects (PROMA)

Design of a Mobility Protocol to Assess the Impact of Visual Pathologies in Daily Life Activities for Subjects With Advanced Visual Deficits

Retinitis Pigmentosa is characterized by a progressive disappearance of photoreceptors, responsible for a progressive and severe loss of vision.

People Retinitis Pigmentosa therefore encounter a large number of difficulties in daily life, specifically for:

• Visual research
• Visuo-motor coordination in tasks requiring fine motor control
• Visuo-motor coordination in mobility tasks

This study aims to assess the difficulties in the daily life of subjects with Retinitis Pigmentosa at a very advanced stage unsing, quaify of life questionnaires, simplified locomotion tasks in real situation and a posture task.

They are proposing a new test adapted and carried out in real situations, in binocular and monocular vision, making it possible to finely assess locomotion especially for "very low vision" patients.

This test will also ultimately make it possible to better evaluate the effectivements, that is to say to observe and quantify objectively by a score the performance progression obtained for locomotion tasks related to the visual recovery generated by the treatment.

Study Overview

• Status: Recruiting
• Conditions: Pigmentary Retinopathy
• Intervention / Treatment: Behavioral: Locomotion task; Behavioral: Posturology task SOT (Sensory Organization Test); Behavioral: The quality of life questionnaire

Detailed Description

This is monocentric study and the total duration of the study is 48 months. The duration of participation for each research subject is 3 months and maximum 4 visits. This is research involving the human type of non-invasive interventional research, with minimal risks and constraints.

This exploratory study will be conducted on a group of patients with Retinitis Pigmentosa at a very advanced stage.

There will be an inclusion visit including a visual assessment and an ophthalmological consultation. Two experimental visits with tests carried out in a real environment including a locomotion and a posture tasks. An end-of-study visit within a maximum of 1 month following the second experimental visit.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tania TR RILCY; Phone Number: +33140021126; Email: trilcy@15-20.fr
• Study Contact Backup: Name: Hayet HS SERHANE; Phone Number: +3314021144; Email: hserhane@15-20.fr

Study Locations

• France
  • Paris, France, 75012
    • Recruiting
    • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
    • Contact: Saddek SM MOHAND-SAID, MD; Phone Number: 01400021421; Email: smolhand@15-20.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Retinitis Pigmentosa, non-syndromic, the diagnosis of which has been confirmed by an ophtmalmologist
• ETDRS visual acuity less than 2/10 (>+0.7 logMAR; <20/100 Snellen)
• Doesn't participate in clinical research that may interfere with this study
• Sufficient knowledge of the French language to ensure a perfect understanding of the tasks to be performed and the instructions received
• Consent to the study signed after information by the investigator
• Health insurance affiliation

Exclusion Criteria:

• Pregnant women
• Inability to give personal consent
• Cataract surgery in the 3 months preceding inclusion
• Amblyopia
• Inability to comply with the instructions for carrying out the study tasks or to complete the study visits
• MMSE score without visual item ≤ 20/25
• Drug treatment which can lead to motor, visual or cognitive disorders (PSA, neuroleptics,etc.) or which may interfere with the study's evaluations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Retinitis Pigmentosa patients; 50 patients with very severe Retinitis Pigmentosa

Behavioral: Locomotion task; The locomotion task takes place on a Streetlab platform. The subject must follow a line on the ground, straight or composed of turns.; Other Names: Streetlab platform; Behavioral: Posturology task SOT (Sensory Organization Test); The task takes place on a Streetlab platform with uniform walls without decorations in order to remove any localization element.; Other Names: Streetlab platform; Opal MobilityLab; Behavioral: The quality of life questionnaire; Study the correlations between the subjects' quality of life scores and the results during behavioral tests. Identify the subjective parameters most sensitive to sensory-motor performance.; Other Names: NEI-VFQ-25; ULV VFQ (Ultra Low Vision Visual Funnctioning Questionnaire)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discriminating	Study of the correlation between the severity of the impairment with regard to visual evaluations (visual acuity, visual field, ect) and the performance score for locomotion and posture tests.	Month 1
Reproducibility	Graphical and tabular representations will be prepared to represent the correlation between test results and visual function measures on the one hand and daily life activities on the other.	Month 1
Validity of construction	Graphical and tabular representations will be prepared to represent the correlation between test results and visual function measures on the one hand and daily life activities on the other.	Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of postural parameters	The locomotion task which takes place in a Streetlab platform. The subject must follow a line on the ground, straight or composed of turns. For the other tests, the number of turns and the distance to be covered are identical, but the shapes of the courses are systematically different. The posturology task SOT (Sensory Organization Test) takes place in a StreetLab platform with uniform walls without decorations so as to remove any localization element. The subject is instructed to stand with his hands on his hips as steadily as possible. This test includes 4 experimental conditions for disturbing sensory inputs. the duration of acquisition is 30 seconds, during which the subject must hold a standing position as tatic as possible, without speaking, els hands positioned on the hips while looking straight ahead. Four experimental conditions are tested: Eyes open on a hard floor, eyes closed on a hard floor, eyes open on a foam tray, eyes closed on a foam tray.	Month 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
• Investigators: Principal Investigator: Saddek SM MOHAND-SAID, MD, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2020
• Primary Completion (ANTICIPATED): June 2, 2024
• Study Completion (ANTICIPATED): June 4, 2024

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (ACTUAL): June 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis Pigmentosa
• Other Study ID Numbers: P19-04; 2019-A00937-50 (OTHER: IDRCB Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No